DESERET THERMODILUTION CARDIAC OUTPUT

Computer, Diagnostic, Pre-programmed, Single-function

PARKE-DAVIS CO.

The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Deseret Thermodilution Cardiac Output.

Pre-market Notification Details

Device IDK841967
510k NumberK841967
Device Name:DESERET THERMODILUTION CARDIAC OUTPUT
ClassificationComputer, Diagnostic, Pre-programmed, Single-function
Applicant PARKE-DAVIS CO. 2337 PARKDALE AVE. Brookville, Ontario,  CA K62 5ws
Product CodeDXG  
CFR Regulation Number870.1435 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-15
Decision Date1985-08-19

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